Ranibizumab Treat and Extend in Diabetic Macular Edma

An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized Treat and Extend Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01297569

Acronym

OPTIMAL

Enrollment

Registered

2011-02-16

Start date

2011-01-31

Completion date

2012-11-30

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edema, Macular edema, DME, Diabetic retinopathy, Diabetic eye disease, anti-VEGF, ranibizumab, Lucentis

Brief summary

This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.

Interventions

DRUGRanibizumab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Visual impairment due to focal or diffuse macular edema with center involvement * Diabetes type 1 or 2, HbA1c \< 12.0% * CRT = or \> 250 μm

Exclusion criteria

* Active inflammation or infection * Uncontrolled glaucoma * Iris neovascularization, active proliferative retinopathy or vitreomacular traction * Prior laser photocoagulation according to defined timelines * History of stroke, uncontrolled hypertension Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change in Best Corrected Visual Acuity(BCVA)	from month 0 (baseline) to month 12

Secondary

Measure	Time frame
change in central retinal thickness (CRT)	from month 0 to month 12
the number of injections needed	12 months
the number of patients with improvement in BCVA from baseline	12 months
the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84	12 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026